FDA Proposes Ban of Certain ESDs

Ban would affect devices used to treat aggressive/self-injurious behavior

In a landmark move, the U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation devices (ESDs) designed to reduce or stop self-injurious or aggressive behavior. This significant step, rarely taken by the agency, comes after thorough evaluation of the risks associated with these devices.

Attributed to Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, the proposal highlights the determination that ESDs present an unreasonable and substantial risk of illness or injury. Notably, individuals who exhibit such behaviors, often with intellectual or developmental disabilities, face psychological risks like depression and anxiety, alongside physical risks such as pain and tissue damage.

Impact of a proposed ban

The proposed rule aims to remove ESDs from the market entirely, rendering them legally unavailable for use. Currently, only one facility, the Judge Rotenberg Education Center in Canton, Massachusetts, utilizes these devices, affecting approximately 50 individuals. The FDA acknowledges the need for a gradual transition away from these devices and intends to consider the needs of affected patients if the ban is finalized.

This proposal follows a previous ban in 2020, which was annulled due to legal interpretation issues. However, recent changes to the Federal Food, Drug, and Cosmetic Act have clarified the FDA’s authority to issue such bans for specific intended uses, reinforcing the agency’s stance on ESDs for self-injurious or aggressive behavior.

Rationale

The decision to propose the ban is backed by comprehensive analysis of clinical data, scientific evidence, expert input, and feedback from stakeholders. Importantly, the new information reaffirms the FDA’s previous determinations regarding the risks associated with these devices.

It’s crucial to note that the proposed rule specifically targets ESDs for self-injurious or aggressive behavior and does not affect devices intended for other purposes, such as aversive conditioning for smoking cessation.

Overview of ESDs and therapeutic uses

Electrical stimulation devices typically have similar components and are used in a variety of treatments. Read more about ESDs.

Public comment sought

The proposal invites public comment until May 28, 2024, after which the FDA will review and consider feedback before making a final decision. This move underscores the agency’s commitment to prioritizing patient safety and ensuring the appropriate use of medical devices in the healthcare landscape.

FDA Proposal Notice